Clinical trial

A Multicenter, Open-label, Phase II Study to Explore Efficacy and Safety of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa

Name

STS-BDB001-08

Description

The purpose of this study is to explore whether BDB-001 Injection is effective and safe in the treatment of moderate to severe hidradenitis suppurativa(HS).

Trial arms

Trial start

2021-08-18

Estimated PCD

2023-08-22

Trial end

2023-08-22

Status

Completed

Phase

Early phase I

Treatment

BDB-001 Injection

Multiple IV infusions of BDB-001 Injection diluted in sodium chloride

Arms:

Treatment group

Size

Primary endpoint

Change in International Hidradenitis Suppurativa Severity Score System (IHS4) score from Day 0 by time point

Week 8

Eligibility criteria

Inclusion Criteria: * Subjects who signed the informed consent to participate in the STS-BDB001-06 clinical study and completed all follow-up of the study as required by the protocol, or who withdrew early due to treatment failure or other objective reasons and completed the early withdrawal visit (at least 4 weeks of treatment) Exclusion Criteria: * Never participated in the clinical study of STS-BDB001-06； * Subjects withdrew from the STS-BDB001-06 clinical study due to an intolerable adverse event related to the study drug.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 41, 'type': 'ACTUAL'}}

Updated at

2023-08-29

1 organization

1 product

1 indication

Organization

Staidson Biopharmaceuticals

Product

BDB-001

Indication

Hidradenitis Suppurativa